Fast Five Medtech News Podcast

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. Ventricu...

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...

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. AngioDyn...

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...

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 peopl...

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...

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 ad...

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 delive...

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 duri...

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...

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 breakthroug...

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 i...

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...

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 expand...

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 visualizatio...

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 annou...

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...

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% i...

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...

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...

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 si...

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...

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...

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 cleara...

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 commercial...