Asensus Surgical wants to incorporate artificial intelligence in its surgical robotic platforms and has partnered with Nvidia. Fast Five hosts Sean Whooley and Danielle Kirsh explain the goal of the partnership and how Asensus plans to use Nvidia's tools. Align Technology this week launched its Invisalign palatal expanders. Find out what features are included in the palatal expanders and how they differ from gold standard methods. Inogen's CFO is stepping away from the company and the company na...
Sep 08, 2023•10 min
Admetsys this week won FDA breakthrough designation for its automated glucose control technology. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the glucose control system does and what executives are saying. Moximed has implanted its first Misha knee implantable shock absorber in the U.S. Find out what an implantable shock absorber is and what doctors think about it. GE HealthCare and Mass General are collaborating on AI algorithms to predict missed care opportunities, expanding o...
Sep 07, 2023•11 min
Axogen this week announced it launched its AxoGuard HA+ nerve protector. Fast Five hosts Sean Whooley and Danielle Kirsh share details on what AxoGuard is and why it is essential from a doctor's perspective. The surgical robotics space is expanding. Ronovo Surgical announced it raised $26 million in capital for its surgical robotic platform. Whooley explains what the surgical robot is designed for, what it gives surgeons and what Ronovo Surgical plans to do with the raised capital. Restor3d's ac...
Sep 06, 2023•11 min
Glucotrack is back in this news, this time with news of a former Medtronic veteran being tapped for its board director spot. Fast Five hosts Sean Whooley and Danielle Kirsh go over the new appointee and their career history. Zeiss Medical Technology this week announced it intends to unveil new ophthalmic innovations within its cataract and corneal refractive workflows. Find out what updates the company is planning to make and what executives are thinking. LivaNova has received FDA 510(k) clearan...
Sep 01, 2023•10 min
Aion Biosystems announced this week that it won FDA 510(k) clearance for its iTempShield device and software system. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the system is, how it works and what executives are saying about the FDA clearance. Over-the-counter Narcan just became available with Emergent BioSolutions' recent launch. Find out about the company's FDA approval to get to this point and how it will become available to consumers. Myomo has closed a $4.4 million public ...
Aug 31, 2023•9 min
Implantable continuous glucose maker Glucotrack announced it has a new VP of marketing. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the new VP and their career history that supports the appointment. Haemonetics is expanding its global presence by launching its vascular closure device in Europe. Find out which device is going global, how it works and what's next for Haemonetics. The FDA granted 510(k) clearance to ICU Medical's infusion pump and software. Whooley explains what the ...
Aug 30, 2023•10 min
SmileDirectClub and Align Technology are in a legal proceeding from a previous partnership. Fast Five hosts Sean Whooley and Danielle Kirsh discuss SDC's plans to appeal a court order that said it has to pay Align Technology $63 million. In today's episode, find out more about the proceeding and the SmileDirectClub's appeal. GE Healthcare has unveiled its latest wireless, handheld ultrasound device. Whooley explains what the device does, how accompanying digital tools help clinicians and what ex...
Aug 29, 2023•12 min
This week, the FDA granted a fast-track designation for Nectero Medical's end-vascular aneurysm stabilization treatment system. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the system works and what executives say about this FDA win. There's more AFib news on the horizon, this time from GE Healthcare. The company launched its CardioVisio digital tool for helping to treat AFib. Find out what the system does and the ultimate goal for GE Healthcare. SPAC mergers are back in the news ...
Aug 25, 2023•11 min
Masimo this week announced the launch of its Stork home baby monitoring system. Fast Five hosts Sean Whooley and Danielle Kirsh explain how the system works and how it fits in with the flagship products already with the company. Home hemodialysis is on the rise. Fresenius Medical Care recently received FDA 510(k) clearance for its Versi HD with GuideMe software for its chronic home hemodialysis system. Find out when the technology will become available and how executives envision it for use in t...
Aug 24, 2023•10 min
Medtronic's first-quarter results are in, and they were ahead of the consensus forecast on Wall Street. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the company's performance, what contributed to its growth and how each segment performed. Wenzel Spine has received FDA clearance for expanded indications of its primaLOK SP system for spinal fusion procedures. Hear how the system works, what some of the features are and what doctors think about using the device. Surgical robotics continu...
Aug 23, 2023•10 min
Anika Therapeutics received the final FDA 510(k) clearance for its Integrity implant system for improving outcomes in rotator cuff repair procedures through biologic healing. The hyaluronic acid-based patch augments an injured tendon, promoting rotator cuff healing. Fast Five hosts Sean Whooley and Danielle Kirsh delve into how the device works and what the regulatory nod means for Anika. Ventricular assist devices save lives and another one may soon be entering the fold. MagAssist won FDA break...
Aug 22, 2023•11 min
Nemaura Medical received regulatory approval in the Middle East for its sugarBEAT sensor for glucose monitoring. The regulatory win comes after it received a provisional purchase order for more than 1 million sensors and thousands of devices. Fast Five hosts Sean Whooley and Danielle Kirsh go over what the sugarBEAT sensor is and some of the other regulatory agencies the company is hoping to gain approval from soon. BlueWind Medical recently won an FDA do novo nod for its Review neuromodulation ...
Aug 18, 2023•10 min
CathVision this week announced the FDA clearance of its PVI Analyzer and Signal Complexity algorithms for facilitating electrogram interpretation. The regulatory nod makes these artificial intelligence-based tools available to physicians. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the algorithms are used for and what sets them apart from traditional EP recording systems. AngioDynamics received FDA breakthrough designation for its AngioVac system. The designation includes propos...
Aug 17, 2023•10 min
People living with diabetes are always looking for ways to make the management of their chronic condition easier. Welldoc aims to address that with its BlueStar platform, which just received its 10th FDA clearance, this time for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Fast Five hosts Sean Whooley and Danielle Kirsh break down what BlueStar does and how this latest regulatory nod boosts Welldoc. The episode also covers FDA authorization for anothe...
Aug 16, 2023•10 min
Artificial intelligence is making its way through the medtech industry. iCad recently announced plans to integrate Google AI into its ProFound Breast Health Suite for 2D mammography. Fast Five hosts Sean Whooley and Danielle Kirsh go over how the company wants to use AI and the details of its existing partnership with Google. A new study from Edwards Lifesciences offers potential support for people with hypotension. Results from a study showed that using Acumen HPI may help reduce the duration a...
Aug 15, 2023•10 min
In this episode, Fast Five hosts Sean Whooley and Danielle Kirsh break down some of the second-quarter highlights for Insulet as it continues to report impressive revenue growth. The automated insulin delivery technology developer offered even more optimism for the rest of the year, raising its guidance as sales of the Omnipod system are taking off. There's also promising news on the product side as Insulet recently shared an update on the progress of the Omnipod's integration with a popular con...
Aug 10, 2023•10 min
MassDevice remains the place to go if you want the rundown on earnings season in medtech. This episode's coverage includes a discussion of Masimo's second-quarter performance, which included a significant reduction in the company's 2023 sales guidance. Fast Five hosts Sean Whooley and Danielle Kirsh break down what contributed to the results and why Masimo remains optimistic in the face of some adversity. Elsewhere, more medtech companies are looking to raise awareness of their offerings through...
Aug 10, 2023•11 min
Earnings season continues on MassDevice. Acutus Medical posted Street-beating Q2 results and gave an update on when it expects to receive approval for its AcQBlate ablation catheter. Fast Five hosts Sean Whooley and Danielle Kirsh provide details about the pending approval and what contributed to the company's sales growth in the quarter. Embecta reported progress on its closed-loop insulin delivery technology in its quarterly earnings results. Find out the status update on that system and what ...
Aug 09, 2023•11 min
Tivic Health this week announced that it priced a public offering of common stock. The company plans to use the net proceeds for working capital and general corporate purposes. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the offering includes and give details on the upcoming special stockholder meeting. Masimo's SedLine brain function monitoring could improve brain monitoring during endoscopy, according to a new study. Find out the key details of the study and how it assesses se...
Aug 08, 2023•10 min
Movano is submitting its smart ring for pulse oximetry to the FDA. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the clinical performance of the smart ring and how it could be a competitive differentiator. Henry Schein is making a homecare play with the acquisition of Shield Healthcare. Henry Schein officials see the move as bolstering the company’s commitment to facilitating a continuum-of-care delivery model. Hear how the acquisition fits into the company's strategic plan and what ty...
Aug 04, 2023•11 min
Glytec this week unveiled the newest version of its Glucommander insulin dosing software that enables best practice, personalized care. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the update and what it offers in workflow improvements for patients and physicians. Water vapor ablation could become the latest treatment option for prostate cancer. Francis Medical received FDA breakthrough designation for its water vapor ablation therapy this week. Find out how the technology works and w...
Aug 03, 2023•10 min
Earnings season continues in the medical device industry. Hologic posted its Q3 results this week, and it was a mixed bag. Investors and analysts have questions about future margins. Fast Five hosts Sean Whooley and Danielle Kirsh review the company's performance and the analysts' views. The FDA recently granted expanded indication to Teleflex's QuikClot Control+ hemostatic device. The expanded indication may allow Teleflex to target new clinical applications. Find out what the expanded indicati...
Aug 02, 2023•11 min
The recent collaboration between Henry Schein and Medpod signifies an increased focus on telehealth solutions and the integration of diagnostic technologies. Fast Five hosts Danielle Kirsh and Sean Whooley discuss how the Medpac system serves as a telediagnostic offering and the benefits it offers patients and providers. Inspire Medical recently appointed a former AppliedVR executive as its chief medical officer. The move highlights the significance of medical leadership in driving strategic dec...
Aug 01, 2023•10 min
Philips' collaboration with CoxHealth showcases the growing importance of virtual care solutions in the post-COVID era. Fast Five hosts Danielle Kirsh and Sean Whooley discuss the aim of the collaboration and some of the feedback and reactions from clinical staff about the virtual care delivery program. Asensus Surgical's $10M offering indicates its efforts to secure financial resources for expanding its surgical robotics technology and bringing its innovative products to a broader market. Find ...
Jul 28, 2023•11 min
LivaNova's Q2 performance and increased 2023 guidance indicate the company's ability to adapt to market challenges and capitalize on growth opportunities. The Fast Five hosts discuss the company's financial performance, which segment had the greatest growth and what the CEO had to say about the quarterly earnings. Olympus recently launched its EasySuite ES-IP system for procedure room visualization and integration in the U.S. Whooley explains some of the features and capabilities of the new syst...
Jul 27, 2023•9 min
GE HealthCare's strong Q2 performance and raised guidance signal a positive outlook for the company. The standalone GEHC should benefit from a number of underlying growth drivers in the future as well. Fast Five hosts Sean Whooley and Danielle Kirsh explain what factors contributed to the company's growth and how analysts view performance and prospects. NeuroOne Medical Technologies recently announced it priced an underwritten registered public offering. The proceeds from the offering may accele...
Jul 26, 2023•10 min
Philips recently announced Q2 results and an update on the ongoing DOJ talks and layoffs. Industry analysts may discuss Philips' forward-looking plans to mitigate order intake volatility and maintain a competitive edge in the medical device market. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the quarterly results and what the current status of the ongoing consent decree. The launch of Biosense Webster's AFib mapping catheter signifies J&J's commitment to advancing cardiac ablatio...
Jul 25, 2023•10 min
Abbott has now seen two quarters in a row of double-digit organic sales growth in its underlying business. Now the company is betting on its productive, innovative pipeline to build momentum. Fast Five hosts Sean Whooley and Danielle Kirsh go over the full performance of the company and how each of its segments performed. Johnson & Johnson MedTech posted revenues of $7.9 billion, marking a 12.9% improvement year-over-year. Learn what the growth drivers were for the MedTech segment and what a...
Jul 20, 2023•11 min
Aetna's policy update expanding access to Neuronetics NeuroStar represents a positive step towards increasing patient accessibility to innovative depression treatment options. Fast Five hosts Sean Whooley and Danielle Kirsh explain what NeuroStar is and the policy update that expands access to the technology. Biostrap announced that it launched its new Kairos wearable device for data visualization of the autonomic nervous system. Such devices can potentially empower individuals to monitor their ...
Jul 20, 2023•12 min
The appointment of a former Medtronic executive as CFO of ForSight Robotics brings valuable industry experience and expertise to the company's leadership team. Fast Five hosts Sean Whooley and Danielle Kirsh discuss who was appointed and why the company decided to appoint them. Philips' enrollment of the first patients in a stroke diagnosis and treatment trial showcases the company's commitment to advancing stroke care and improving patient outcomes through clinical research. Listen to today's e...
Jul 19, 2023•10 min
