Q&A: Dexcom’s Lawver shares strategy behind CGM for non-insulin users

The continuous glucose monitor in development for people with Type 2 diabetes who don’t take insulin could expand the CGM market to 25 million more people in the U.S., the company’s new chief commercial officer said.

By Elise Reuter • June 30, 2023

Diabetes remains fastest-growing medtech market despite some risk from new drugs: analysts

The medicines could apply “short-lived pressures” to medtech companies by affecting the use of insulin, Mizuho analysts say. 

By Nick Paul Taylor • June 30, 2023

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New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

EU MDR costs could cause device shortages for children, medical groups warn

The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.

By Elise Reuter • June 29, 2023

FDA seeks feedback on technologies that can enable healthcare at home

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

By Nick Paul Taylor • June 29, 2023

FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use

The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.

By Nick Paul Taylor • June 29, 2023

Former J&J sales rep indicted on charges of defrauding Boston hospital

The former J&J employee is accused of bilking the hospital out of hundreds of thousands of dollars’ worth of spine products.

By Susan Kelly • June 28, 2023

Teleflex recall of separating vascular catheters labeled Class I event

The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.

By Nick Paul Taylor • June 28, 2023

Invacare names Kai Zhu as CFO

The promotion positions Zhu to help lead the manufacturer of non-acute care medical equipment as it works to recover from a bankruptcy filing.

By Nick Paul Taylor • June 28, 2023

Proposed EtO limits garner criticism from device industry, praise from occupational health groups

Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.

By Elise Reuter • June 27, 2023

Masimo shareholders elect activist investor’s two board candidates

The vote approving Politan Capital’s nominees is “a clear mandate from shareholders that significant change is needed at Masimo,” said newly elected director Quentin Koffey.

By Susan Kelly • Updated June 27, 2023

Restor3d inks Conformis buyout, adding hip and knee implants to portfolio

Restor3d, which makes 3D-printed devices for spine, ankle and upper extremity procedures, is buying Conformis at a 96% premium. 

By Nick Paul Taylor • June 27, 2023

More than 1 billion people could have diabetes by 2050, study says

A pair of studies published in the Lancet show that spending on diabetes care is expected to rise, but more work is needed to address structural inequities that affect access to treatment.

By Elise Reuter • June 26, 2023

Medtronic links 780G insulin pump to benefits in kids as it works to grow sales

A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.

By Nick Paul Taylor • June 26, 2023

Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics

The device will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.

By Nick Paul Taylor • June 26, 2023

Showdown at Masimo: Proxy battle targets CEO Kiani’s leadership, board

Shareholders are voting on whether to add investor Politan Capital’s picks to the board of the pulse oximeter maker, a move that could change the company’s direction.

By Susan Kelly • June 23, 2023

Intuitive’s Ion platform may provide ‘most exciting advancements in robotic technology’: analysts

Intuitive’s da Vinci robotic surgery platform is the most widely used robot in the industry and analysts expect demand for bronchoscopy and tumor ablation to fuel growth for the company’s Ion system. 

By Nick Paul Taylor • June 23, 2023

Sterigenics moves closer to end of ethylene oxide lawsuit as most claimants accept $408M deal

The agreement allows the company to put the lawsuits behind it, while leaving Sterigenics’ future open as U.S. regulators push to limit the use of the medical device sterilization chemical.

By Nick Paul Taylor • June 23, 2023

Medtronic will distribute Allurion’s swallowable weight-loss balloon

An innovation in obesity treatment can extend the benefits of bariatric intervention to the overweight without the need for surgery, and will be tried in developing markets of eastern Europe, the Middle East and Africa.

By Susan Kelly • June 22, 2023

GE HealthCare partners with J&J to push spine imaging system

Striking the deal to bring its OEC 3D systems and DePuy Synthes devices to U.S. surgeons continues the streak of partnerships formed by GE HealthCare to broaden the distribution of its products.

By Nick Paul Taylor • June 22, 2023

Owlet receives FDA clearance for prescription pulse oximetry baby sock

Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.

By Nick Paul Taylor • June 22, 2023

Proposed breast cancer screening recommendations don’t go far enough

A proposal by a government-sponsored task force calling for a 24-month spacing between mammograms fails to address the latest research and may further exacerbate disparities and mortality outcomes, argues Henry Izawa, head of FujiFilm Healthcare Americas.

By Henry Izawa • June 21, 2023

Surgalign files for bankruptcy, agrees to sell US hardware unit for $5M

Surgalign also disclosed that it is laying off 25 employees and eliminating the position of chief commercial officer.

By Nick Paul Taylor • June 21, 2023

Philips gets slapped with two legal challenges by French patients in ‘Respiratorgate’

A civil case covers 1,341 claimants who seek compensation for non-material damages tied to a failure to provide adequate information and for what they say is anxiety-related harm.

By Nick Paul Taylor • Updated June 22, 2023

BD plans $540M sale of surgical instrumentation platform to Steris

The divestiture is part of BD’s strategy to simplify its portfolio and focus on higher-growth markets.

By Peter Green • Updated June 20, 2023

Surmodics secures FDA nod for PAD balloon, earning payment from Abbott

The company will challenge Medtronic’s IN.PACT Admiral device to treat peripheral arterial disease with a balloon that is coated with a lower dose of paclitaxel.

By Susan Kelly • June 20, 2023