Tivic Health's successful pricing of a $2.1 million offering reflects investor confidence in the company's innovative medical device solutions. The offering comes just days after the company closed another $1.8 million offering of common stock. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the offer includes and when it will close. The collaboration between Glaukos and Radius XR signifies the growing adoption of wearable diagnostics in ophthalmology, aiming to improve disease moni...
Jul 18, 2023•9 min
Boston Scientific received FDA approval for image-guided programming software, advancing deep brain stimulation treatments for neurological conditions. Fast Five hosts Sean Whooley and Danielle Kirsh review what the software offers clinicians. Henry Schein recently secured a $750 million credit facility, fueling its growth and ability to provide quality products and services in the medical device industry. Learn about the credit facility's maturity, what executives are saying, and some of the bu...
Jul 14, 2023•11 min
Olympus this week announced positive study data for its minimally invasive iTind treatment for enlarged prostate symptoms. Fast Five hosts Sean Whooley and Danielle Kirsh go over what that treatment option is, how it works and what some of the study results showed. Eitan Medical's launch of a cloud-based infusion management platform reflects the integration of digital technologies into healthcare, aiming to enhance patient safety and optimize medication administration. Learn more about what Eita...
Jul 13, 2023•10 min
Heart failure is a prevalent condition that requires effective management and monitoring to improve patient outcomes and quality of life. Shifamed portfolio company Adona Medical recently introduced its next-generation heart failure platform. Fast Five hosts Sean Whooley and Danielle Kirsh detail the technology that is featured in the system and how it works to enhance patient care. The FDA clearance of Tandem Diabetes Care's Mobi durable automated insulin pump reflects the ongoing advancements ...
Jul 12, 2023•10 min
The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market. PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the tec...
Jul 11, 2023•11 min
Microbot Medical's completion of a pre-clinical study for its endovascular surgical robot signifies a significant milestone for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the surgical robot does and what the outcome of the pre-clinical study was. The FDA clearance of Boston Scientific's Embold Soft & Packing coils demonstrates the company's commitment to expanding its portfolio of innovative solutions for embolization procedures. Hear about what the coils are d...
Jun 30, 2023•10 min
A study demonstrating the health equity impact of Virta Health's diabetes reversal platform highlights the potential of digital health solutions in addressing disparities in healthcare outcomes. Fast Five hosts Sean Whooley and Danielle Kirsh go over the critical points of the study and who the company found is most affected by diabetes. BioSig's expansion of research and development efforts in machine learning and artificial intelligence (AI) for cardiac arrhythmia treatment signifies the growi...
Jun 29, 2023•10 min
Sernova's positive interim data for the Cell Pouch System highlights the potential of regenerative medicine in addressing various medical conditions. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the key findings in the data in today's episode. Ultra-low frequency neuromodulation has the potential to revolutionize the field by offering more precise and targeted treatment options. Presidio Medical recently raised $72 million for its ultra-low frequency neuromodulation, and Whooley has a...
Jun 28, 2023•10 min
Continuous glucose monitoring (CGM) systems have revolutionized diabetes management by providing real-time data on glucose levels, and new data supports the safety and accuracy of Senseonics 365-day CGM. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the study's key findings. Aortic aneurysms pose significant health risks. The FDA's approval of Cook Medical's endovascular graft trial represents a positive development in treating this condition. Hear how Cook Medical wants to make the go...
Jun 27, 2023•11 min
Teleflex's voluntary recall of its Rüsch endotracheal tubes highlights the possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation. Fast Five hosts Sean Whooley and Danielle Kirsh share what issue caused the recall and how many complaints the company has received so far. The FDA's IDE approval of Metavention's renal denervation therapy represents an important milestone in the treatment of hypertension....
Jun 23, 2023•10 min
The availability of Insulet's Omnipod 5 automated insulin delivery system in the UK is a significant development in diabetes management. Fast Five hosts Sean Whooley and Danielle Kirsh explain the system's impact on people with diabetes in the regions where it is already available and where the company plans to launch next. Teleflex's partnership with Insighters Medical to distribute Insighters' video laryngoscope is an exciting development in airway management. Whooley provides the details of t...
Jun 22, 2023•11 min
The partnership between Nuwellis and DaVita to launch an ultrafiltration therapy pilot program is an exciting development in the field of renal care. The agreement enables Nuwellis — formerly CHF Solutions — to pilot its Aquadex ultrafiltration therapy within selected U.S. markets. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the partnership in detail and what executives say about it. CorWave's successful fundraising of $64 million is a significant milestone for the company as it prep...
Jun 21, 2023•11 min
The release of positive 2-year data supporting the Endologix Detour system is significant news in the field of peripheral arterial disease (PAD) treatment. This data provides strong evidence of the system's long-term efficacy and durability in managing PAD, a condition that affects a significant number of individuals globally. Fast Five hosts Sean Whooley and Danielle Kirsh explore the data behind the study. Relievant Medsystems' positive data highlights the potential of nerve ablation as a mini...
Jun 16, 2023•12 min
The FDA's approval of a new peripheral arterial disease (PAD) treatment from Endologix marks a significant milestone in addressing this prevalent condition. PAD affects millions of people worldwide, and this approval provides healthcare professionals with an additional treatment option to improve patient outcomes. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the device is and how it works to improve patient outcomes. Surmodics recently received FDA 510(k) clearance for its Pounce...
Jun 15, 2023•11 min
Gore's initiation of a study to compare the VBX stent graft with metal stenting highlights their commitment to advancing the field of vascular interventions. This study aims to provide valuable insights into the safety and efficacy of different treatment options, ultimately improving patient outcomes. Fast Five hosts Sean Whooley and Chris Newmarker explain the details of the study, including the primary endpoint and how doctors feel about the device and study. Bioretec's decision to increase pr...
Jun 14, 2023•14 min
NeuroOne's submission of its RF ablation system for FDA 510(k) clearance marks a significant step forward in its pursuit of providing advanced treatment options for patients. If granted clearance, this technology could offer healthcare professionals a valuable tool in treating various medical conditions, potentially improving patient care and quality of life. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the technology works. Neuronetics' recent FDA clearance for its OCD motor thre...
Jun 13, 2023•12 min
Obvius Robotics' successful completion of the first human cases with the Certa access system represents a significant milestone for the company. Obvius Robotics' achievement highlights the ongoing progress in robotic-assisted surgery, where companies strive to develop solutions that improve surgical precision, reduce invasiveness, and minimize patient recovery time. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the technology and what doctors think about the technology. The study suppo...
Jun 09, 2023•11 min
The FDA clearance of Teleflex's Wattson temporary pacing guidewire represents an important milestone in cardiac care for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain how the technology works and what executives hope to achieve with the device. Inari Medical's launch of its RevCore and Triever16 Curve catheters marks a significant development in the field of endovascular care. These catheters offer advanced capabilities for the treatment of venous and arterial diseases, pr...
Jun 08, 2023•11 min
The FDA clearance of DeepX Diagnostics' teledermatology screening solution marks a significant advancement in remote dermatological care. This innovative technology allows healthcare professionals to assess and diagnose suspected skin cancer lesions remotely, potentially improving access to timely and accurate dermatological evaluations. Fast Five hosts Sean Whooley and Danielle Kirsh share details about the system and what the company essentially hopes to achieve with the technology. Avatar Med...
Jun 07, 2023•12 min
Sparrow BioAcoustics' FDA clearance for their smartphone stethoscope marks a significant advancement in remote patient monitoring and telehealth. This innovative technology allows healthcare professionals to capture and analyze heart and lung sounds using a smartphone, enabling more accessible and convenient monitoring of patients' respiratory health. Fast Five hosts Sean Whooley and Danielle Kirsh have all the details. The FDA clearance of GE Healthcare's Sonic DL AI technology for expediting M...
Jun 06, 2023•11 min
The FDA clearance obtained by startup Ezra for its AI technology marks a significant milestone for the company. Ezra wants to reduce MRI times to 15 minutes. Hear more from Fast Five hosts Danielle Kirsh and Chris Newmarker as they outline what the technology does and its potential to streamline MRI scans. B. Braun recently launched its DoseTrac Enterprise infusion management software for hospital systems. The technology can connect up to 40,000 different infusion pumps at once. Get the details ...
Jun 02, 2023•16 min
The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system. With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and t...
Jun 01, 2023•14 min
The partnership between HeartBeam and Samsung is a significant development in the field of cardiac care, as it combines HeartBeam's expertise in cardiac services with Samsung's global reach and technological prowess. Fast Five hosts Danielle Kirsh and Chris Newmarker have all the details of the partnership. Concept Medical's FDA IDE approval for the sirolimus-coated balloon MagicTouch PTA is a significant development in the treatment of superficial femoral artery disease. This approval allows fo...
May 31, 2023•17 min
Medtronic, as a leading medical device company, plays a significant role in the industry, and its stock performance is closely watched by investors and industry experts. The recent dip in Medtronic's stock can be attributed to the company's growth projections falling short of market expectations. Fast Five hosts Sean Whooley and Danielle Kirsh outline the company's performance in the last quarter and what it anticipates for the future. HeartBeam's win of an AI-related patent for its handheld vec...
May 26, 2023•15 min
Artivion has received FDA premarket application approval for its PerClot absorbable hemostatic system, designed to control bleeding in surgical procedures. The approval marks a significant milestone for Artivion, which will now transfer full ownership to Baxter following a sale agreement in July 2021. Fast Five hosts Sean Whooley and Danielle Kirsh give all the details of the transaction and what technology is involved in PerClot. Stryker has announced that surgeons have initiated early product ...
May 25, 2023•14 min
Companies often make strategic decisions to divest non-core businesses to optimize their focus and resources on areas where they have a competitive advantage. Bioventus' recent completion of the wound business divestiture marks a strategic move to streamline its focus and resources on core areas of expertise. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the financial details of the divestiture. The FDA's approval of another nasal spray for treating opioid overdose represents a positiv...
May 24, 2023•13 min
Abbott recently released significant data backing the use of its Aveir dual-chamber leadless pacemaker. This data provides valuable insights into the device's performance, efficacy, and safety. Fast Five hosts Sean Whooley and Danielle Kirsh dive into the details of the study, examining the key findings and their implications for patients who may benefit from this advanced pacemaker technology. Moving on to Boston Scientific, which has shared positive data on two of its notable devices: Farapuls...
May 23, 2023•11 min
In a significant development, the FDA has cleared Abbott's insertable cardiac monitor, marking an important advancement in cardiac care. This device offers healthcare professionals a valuable tool for long-term monitoring of patients' heart rhythms, enabling early detection and timely intervention. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the device does and how optimistic executives at the company are. Paradromics has raised $33 million in funding. This substantial investment...
May 19, 2023•11 min
Moon Surgical, a promising player in the field of surgical robotics, has successfully raised $55.4 million in funding to support the development of its surgical robot platform. This significant investment indicates growing confidence in Moon Surgical's technology and its potential to revolutionize surgical procedures. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the company's technology and what those new funds are earmarked for. In a creative and impactful move, Hologic has partnered...
May 18, 2023•13 min
Intuitive Surgical, a leader in robotic surgery systems, announced executive changes in its management team this week. Fast Five Hosts Danielle Kirsh and Sean Whooley detail the shake-up at the company, including who was promoted to president and EVP and chief strategy and corporate operations officer. Gary Guthart, who has been CEO since 2010, still remains at the helm. Promising news in the field of pain management as the FDA approves Abbott's spinal cord stimulation devices for non-surgical b...
May 17, 2023•14 min