Pear Therapeutics files for Chapter 11 bankruptcy

The maker of subscription apps for insomnia and substance abuse began exploring strategic alternatives earlier this month, and is still seeking a sale.

By Elise Reuter • April 7, 2023

Bain leads $215M investment in AI startup that analyzes coronary artery disease

HeartFlow’s software models a patient’s coronary arteries from imaging, which cardiologists can use to determine the best course of treatment.

By Elise Reuter • April 6, 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

Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

By Nick Paul Taylor • April 4, 2023

Grassroots innovation: How a patient-driven device for diabetes won FDA clearance

Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January. 

By Elise Reuter • April 3, 2023

FDA drafts guidance to ease path to updates for AI-enabled devices

The guidance describes a framework for changes to medical devices that use machine learning.

By Elise Reuter • March 30, 2023

Breast cancer AI company iCAD lays off workers, names new CEO

The company, which reported a net loss on Tuesday, is also exploring strategic alternatives for its Xoft therapy business.

By Susan Kelly • March 29, 2023

Bill would require Medicare to cover breakthrough devices for four years

The bipartisan legislation, if enacted, would speed the coverage determination process for FDA-approved devices.

By Susan Kelly • March 27, 2023

AntennaWare secures patent for wireless tech designed to unlock implant applications

AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.

By Nick Paul Taylor • March 27, 2023

Friday Q&A: Movano takes on the women’s wearables market with a smart ring

Movano Health aims to stand out from the wearables crowd with a women’s health focus and strategy that is centered on obtaining FDA clearances.

By Susan Kelly • March 24, 2023

VR-based pain treatment can be covered as DME, regulators say

The CMS coded AppliedVR’s pain treatment as durable medical equipment, opening a path to insurance reimbursement for similar virtual reality devices.

By Elise Reuter • March 23, 2023

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.

By Nick Paul Taylor • March 23, 2023

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.

By Elise Reuter • March 21, 2023

‘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.

By Elise Reuter • March 20, 2023

Pear, tight on cash, considers strategic alternatives

The digital therapeutics firm is considering a sale, merger, divestiture, licensing, or seeking additional financing. 

By Elise Reuter • March 17, 2023

Friday 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.

By Susan Kelly • March 17, 2023

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.” 

By Elise Reuter • March 16, 2023

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.

By Nick Paul Taylor • March 16, 2023

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.

By Elise Reuter • March 15, 2023

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. 

By Nick Paul Taylor • March 15, 2023

Philips poaches new connected care business leader from Pear

Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.

By Elise Reuter • March 13, 2023

Medtech groups lose challenge to digital piracy rule in device repair case

Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.

By Susan Kelly • March 13, 2023

Device management for mission-critical care: Maximizing efficiency and effectiveness

Reduce the complexity of device fleet management to deliver seamless mission-critical care.

March 13, 2023

iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals

An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.

By Nick Paul Taylor • March 8, 2023

Sooma’s neuromodulation therapy for depression granted FDA breakthrough status

The patient-administered device, which uses a mild electrical current to improve depressive symptoms, showed promising results in a clinical trial. 

By Nick Paul Taylor • March 8, 2023

Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity

If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.

By Nick Paul Taylor • March 6, 2023