FDA teams with Veterans Health Administration to make medtech supply chains more resilient

Rather than amassing reserves of physical supplies, “digital stockpiles” would create a network of trusted suppliers that have the ability to make products at or near the point of use. 

By Nick Paul Taylor • May 24, 2023

Integra recalls all devices made at Boston facility in the past 5 years, pauses production

Integra initiated the recall after an internal investigation found endotoxin testing deviations that can result in postoperative fevers. Analysts at BTIG said the recall raises “bigger questions” about Integra’s management.

By Nick Paul Taylor • May 24, 2023

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

‘Genuine bull market’ underway in medtech stocks, says CNBC’s Cramer

The “Mad Money” show host said shares of medical device companies stand to benefit from pent-up demand for surgeries postponed during the COVID-19 pandemic.

By Susan Kelly • Updated May 23, 2023

Orthopedic markets to return to normal this year as post-pandemic boost fades: analysts

Hip growth should normalize late this year, while the knee and spine markets are expected to slow down by the end of 2024, say analysts at Needham.

By Nick Paul Taylor • May 23, 2023

PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias

In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias. 

By Nick Paul Taylor • May 23, 2023

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.

By Susan Kelly • May 22, 2023

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.

By Nick Paul Taylor • May 22, 2023

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.

By Nick Paul Taylor • May 22, 2023

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.

By Susan Kelly • May 19, 2023

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. 

By Elise Reuter • May 19, 2023

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.

By Nick Paul Taylor • May 19, 2023

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.

By Nick Paul Taylor • May 19, 2023

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.

By Elise Reuter • May 18, 2023

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.

By Nick Paul Taylor • May 18, 2023

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.

By Nick Paul Taylor • May 18, 2023

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.

By Scott Nelson • May 17, 2023

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.

By Susan Kelly • May 17, 2023

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.

By Elise Reuter • May 17, 2023

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.

By Nick Paul Taylor • 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.

By Elise Reuter • 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.

By Susan Kelly • May 16, 2023

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.”

By Nick Paul Taylor • May 16, 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.

By Nick Paul Taylor • May 16, 2023

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.

By Nick Paul Taylor • May 15, 2023

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.

By Nick Paul Taylor • May 12, 2023