Friday Q&A: J&J’s Shan Jegatheeswaran talks about the ‘behind the scenes’ work of AI in medtech

The global head of digital solutions for J&J’s medtech unit says the intersection between software and how it’s used is an important, and often overlooked, aspect of AI.

By Elise Reuter • April 28, 2023

Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test

The company wants to use its Bio-RFID technology for glucose monitoring, and recently showed the device could detect and quantify specific molecules in water. 

By Nick Paul Taylor • April 25, 2023

Report names connected medical devices with the biggest cybersecurity risks

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

By Nick Paul Taylor • April 21, 2023

What medtech startups need to know about remote monitoring

Four medtech executives talked about the future of hospital at home, and the difference between consumer devices and medical devices, in an event hosted by the Colorado Bioscience Association.

By Elise Reuter • April 17, 2023

iCAD, in midst of restructuring, names three new top executives

The mammography AI company last month said it would lay off 28% of its staff to save money.

By Susan Kelly • April 17, 2023

Friday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff

From supporting AI-driven medical interventions to freeing up providers from administrative tasks, remote patient monitoring is raising the bar for care, says Medtronic’s CMO for patient monitoring.

By Susan Kelly • April 15, 2023

OTC hearing aid matches performance of audiologist-fitted device in small trial

People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option. 

By Nick Paul Taylor • April 13, 2023

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

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