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

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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

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

Analysts highlight Masimo’s advantages over Apple, Fitbit ahead of proxy vote

Even as the company faces a battle over its future direction, Stifel analysts said Masimo’s star product could “enhance patient outcomes, optimize care delivery and ‘massively’ reduce costs.”

By Nick Paul Taylor • June 20, 2023

Glass Lewis, joining ISS, supports activist’s candidates for Masimo board

Saying it has “rarely” seen a circumstance where the “need for direct representation of a large shareholder in the boardroom was so apparent,” the proxy advisory firm backed Politan Capital’s bid for two board seats.

By Susan Kelly • June 16, 2023

Robotic surgery market shows no signs of slowing, favoring Intuitive’s da Vinci: J.P. Morgan

The firm polled high-volume surgeons, who said new procedure indications and global expansion will benefit market leader Intuitive Surgical.

By Susan Kelly • June 15, 2023

Interest in elective surgeries up 115% over pre-COVID levels, Google searches show: Needham

The rise in searches correlates with an increase in the size of the market for elective procedures, Needham analysts report, signaling better times for medtech companies.

By Elise Reuter • June 15, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

Masimo proxy fight heats up as ISS backs activist’s board nominees

Institutional Shareholder Services recommended that Masimo shareholders support two board candidates nominated by activist investor Politan Capital Management, setting up a showdown for Masimo’s June 26 annual meeting.

By Susan Kelly • June 14, 2023

Wound repair, custom prosthetics targeted by developers of multi-material bioprinter

Researchers developed a bioprinter that can print multiple materials, allowing them to print cells, drug-releasing meshes and sensors. 

By Nick Paul Taylor • June 14, 2023

Samsung adds heart rhythm notifications to Galaxy Watch to close gap on Apple

The news comes weeks after the FDA granted 510(k) clearance to the new feature, which can be used to detect atrial fibrillation, and positions Samsung to take on other wearable heart monitors from firms including Apple.

By Nick Paul Taylor • June 14, 2023