The Latest
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SonderMind acquires technology from Mindstrong ahead of digital health startup’s shutdown
Mindstrong’s collapse comes in a turbulent period for the digital health sector.
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Deep DiveDelays in reporting led FDA to late cancer warning on breast implants, advocates say
Cases need to be better tracked, and the cancer risks should be discussed with patients prior to surgery, patient advocates and physicians said.
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NuVasive shareholders expected to ‘begrudgingly’ back Globus’ $3.1B takeover amid lack of other bidders
Analysts said “none of the other major strategic players were in a position to bid on NuVasive — either because they were not interested or were financially tied up in other areas.”
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Courtesy of Roche
Roche, Lilly team on test for early detection of Alzheimer’s
The tool is intended to help gauge whether patients should receive further evaluation to confirm a diagnosis.
Updated March 22, 2023 -
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Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts
The companies have acquired pulsed field ablation devices in recent years, but one surgeon told analysts he prefers Boston Scientific’s device as it doesn’t require general anesthesia, leading to faster patient turnaround.
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Permission granted by Medtronic
Medtronic, Nvidia to combine forces on AI devices, allowing users to create new software
The companies are working together to allow physicians and developers to build AI applications for Medtronic devices, beginning with the GI Genius endoscopy platform.
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Permission granted by Accelus
Spine robot maker Accelus gains another FDA clearance
The company believes its Remi device, which works with several major imaging systems, can gain traction in the market with its portable design.
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Courtesy of Grail
Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail
The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.
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Justin Sullivan via Getty Images
‘Business as usual?’ Investors weigh in on future of medtech startup financing after SVB collapse
Some VC firms say the impact may be limited, while others expect fundraising challenges to linger.
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Permission granted by Johnson & Johnson
J&J’s Ashley McEvoy named chair of AdvaMed
McEvoy, who is J&J’s worldwide chairman of medtech, will lead the trade association’s board for the next two years.
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YakobchukOlena via Getty Images
Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters
The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma.
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Sarah Silbiger via Getty Images
FDA sets end date for raft of COVID-related shortages that began early in pandemic
Shortages of home-use ventilators and clinical sample concentrators are expected to continue.
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Permission granted by Hyfe
Q&AFriday Q&A: A startup founder tackles the riddle of why we cough
Joe Brew, the founder of three-year-old Hyfe, sees the potential for cough-tracking technology to be as ubiquitous as blood-pressure cuffs.
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Permission granted by Pear Therapeutics
Pear, tight on cash, considers strategic alternatives
The digital therapeutics firm is considering a sale, merger, divestiture, licensing, or seeking additional financing.
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ClarkandCompany via Getty Images
Senseonics grows sales in Q4 despite ‘softer demand’ for CGM implant in US and Germany
Demand in the U.S. was affected by “a little bit of ambiguity on pricing” ahead of a change to Medicare.
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Permission granted by CMR Surgical
Robot maker CMR Surgical appoints new CEO as it looks to ramp system sales
Supratim Bose will now lead the rollout of the company’s Versius system.
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Courtesy of U.S. Food and Drug Administration
Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources
Other groups gave a warmer welcome to the plan, with AdvaMed suggesting specific edits without criticizing the overall approach.
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Permission granted by Osso VR
From ‘huge shock’ to ‘intense relief’: How one medtech startup weathered the collapse of SVB
Osso VR had all of its funds in the failed Silicon Valley Bank, but the company managed the crisis and met payroll.
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Permission granted by iRhythm
iRhythm COO resigns amid restructuring
Douglas Devine will stay on as a consultant through 2024, as the company goes through a restructuring to become “a larger digital healthcare organization.”
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Courtesy of Tandem Diabetes
Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids
If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.
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Courtesy of Medtronic
Medtronic wins CE mark for ablation device, invests in heart failure monitoring company
The Affera system gives physicians a choice between pulsed field ablation and radiofrequency to treat atrial fibrillation.
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SHansche via Getty Images
Medtech trade group pushes UK to support ambitious Software as a Medical Device program
Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts.
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Sittithat Tangwitthayaphum via Getty Images
Joint replacement business likely to be busy for the next year or more: BTIG analysts
A backlog of patients and improved staffing at hospitals and surgery centers have the analysts projecting four to six quarters of growth for firms including Stryker and Zimmer Biomet.
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Novo Nordisk
Novo Nordisk follows Lilly in sharply cutting price of insulin drugs
Responding to policy changes and pressure over high drug costs, the drug maker is reducing the sticker price of four branded diabetes medicines by up to 75%.
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Justin Sullivan via Getty Images
Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched
A review of companies covered by analysts reveals no significant direct exposure to SVB’s failure, but startups dependent on venture capital cash may be affected.
