Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market

Beta Bionics’ device, aimed at people with Type 1 diabetes, has eliminated most of the data entry required by competitors.

Abbott, Boston Scientific, Medtronic share data on heart rhythm devices at conference

A series of recent innovations in pacemaker technology has opened up new markets and set the stage for increased competition.

Vicarious, preparing to take on Intuitive in robotic surgery, names new COO

John Mazzola will oversee operations as Vicarious prepares to seek FDA approval for a robotic surgery system that would take on Intuitive Surgical’s market-leading da Vinci robot.

Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk

A study found the test is a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures.

Precision Lens ordered to pay $487M for kickbacks to eye surgeons in Medicare false-claims case

Luxury vacations and tickets to Broadway shows were used by the Minnesota-based ophthalmologic supply company to induce surgeons to use its products, a federal court ruled. 

A Boston Scientific purchase of Shockwave could be transformative — but at what price?

Boston Scientific has used “tuck-in” acquisitions to boost growth in the past. Some analysts say it should stay the course amid a report the company may make a bid.

Abbott gains edge over cardiac monitor rivals with FDA clearance of 6-year device

Rival devices sold by Biotronik, Boston Scientific and Medtronic have battery lives ranging from three to 4.5 years.

Chinese medtechs post data on renal denervation devices to rival Medtronic, ReCor

The findings validate the technique used by Medtronic and ReCor, while suggesting the U.S. companies will face competition if they target the Chinese market.

Abbott shares data showing benefit of TriClip device amid FDA review

Patients experienced a reduction in tricuspid regurgitation and had improved heart function, according to late-breaking data presented at EuroPCR.

J&J names Jasmina Brooks as president of Biosense Webster

Brooks will lead the company as J&J competes with rivals such as Boston Scientific over cardiac ablation technology.

Clinical trials showcase potential roles for ultrasound in treating cancer, inflammatory disease

The use of ultrasound as a therapeutic device could lead to new treatment options. In one study, patients with brain tumors received an ultrasound implant that allowed a drug to enter the brain.

To lead in medtech, apply best practices from direct-to-consumer businesses

Entrepreneurs who are willing to leverage proven DTC strategies can gain a competitive advantage in medtech, argues Scott Nelson, president and CEO of FastWave Medical.

Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight

Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.

ITC to review ruling that Apple violated Masimo’s patents

If the ITC finds Apple improperly used Masimo’s pulse oximetry technology in the Apple Watch, the commission could ban imports of some Watch versions.

Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device.

Updated May 17, 2023

Philips claims exposure to foam particles in recalled sleep apnea devices unlikely to harm patients

Inhaling foam particles or chemicals from the recalled devices is unlikely to significantly harm patients, Philips argued, but it added that regulators may reach a different conclusion.

Updated May 16, 2023

Intuitive Surgical promotes Dave Rosa to president, Guthart remains CEO

The surgical robot maker said longtime CEO Gary Guthart retains his role and will continue to lead the company.

Cook Medical lays off 500 after ‘significant change’ to operating environment

In a memo to employees, CEO Pete Yonkman said that hourly manufacturing and distribution workers won’t be laid off because demand for Cook Medical’s products “continues to grow.”

Icahn bolstered by another proxy advisor in battle with Illumina

The DNA-sequencing company defended its board chair, John Thompson, and drew attention to a new disclosure that Icahn’s firm is being investigated by the U.S. attorney for the Southern District of New York.

Updated May 15, 2023

Diabetes app developers must generate more data on clinical effectiveness, study says

The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.

Embecta joins Tidepool to develop insulin pump, raises Q2 growth outlook

Embecta advanced its pump project by partnering with Tidepool, a nonprofit that has developed diabetes management software that can work across different brands of pumps and monitors.

Philips agrees to pay SEC more than $62M to settle China corruption charges

Resolving charges that employees, distributors and subsidiaries may have engaged in improper bidding in China lets Philips put the issue behind it without admitting guilt.

AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals

Medtech firms and environmental regulators are at loggerheads as the industry looks for a safe and cost-effective alternative to ethylene oxide for sterilizing reusable devices.

GE HealthCare’s order book raises questions about sales-growth potential, analysts say

BTIG analysts found “lower order growth than what is assumed” and shared concern the medtech company may face challenges just four months after it was spun off from parent General Electric.

Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors

The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.