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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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.

By Nick Paul Taylor • May 12, 2023

Icahn wins proxy firm nod to oust CEO from Illumina board

The recommendation from Glass Lewis is a boost for Icahn’s plan to force change at the DNA sequencer, as he and Illumina’s management battle for proxies ahead of a shareholder vote on May 25.

By Elise Reuter • May 11, 2023

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.

By Nick Paul Taylor • May 11, 2023

NuVasive grows sales in Q1, allaying concerns about impact of $3.1B Globus merger

The growth reflects “increased procedure volumes” and a “continued surge in demand” for NuVasive devices.

By Nick Paul Taylor • May 11, 2023

Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage

Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.

By Elise Reuter • May 10, 2023

Philips loses vote as shareholders push back against handling of respirator recall

The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.

By Nick Paul Taylor • May 10, 2023

New breast cancer screening guidelines could boost mammography sales

Hologic, which makes mammography machines, could see an increase in its installed base, according to Needham analysts.

By Elise Reuter • May 9, 2023

GE HealthCare poaches Baxter’s CFO

Jay Saccaro leaves Baxter after eight years as CFO; Helmut Zodl remains at GEHC to run special projects.

By Elise Reuter • May 9, 2023

Baxter, GE HealthCare, Philips are at risk from changes in hospital spending: Moody’s

Volatility in equipment orders from hospital customers will probably continue for at least the next 12 to 18 months, the analysts said.

By Nick Paul Taylor • May 9, 2023