HD Medical said today that it’s secured FDA clearance for its HD Steth, which uses artificial intelligence to enable clinicians to perform an advanced cardiac evaluation at point-of-care. The FDA clearance covers all three product classification codes of DQD, DQC and DPS for an electronic stethoscope, phonocardiograph and electrocardiograph — all combined into one device. […]
NovaSight raises $8m for lazy eye treatment device
Israeli startup NovaSight announced today that it has raised $8 million in a Series A round meant to support a large multi-center randomized pivotal study of its lazy eye treatment device. Study results will support potential FDA 510(k) clearance for the device. The money will also support development of future eye care products such as […]
Eko names Humbarger as new SVP
Eko announced yesterday that it appointed Bryan Humbarger as its new senior vice president of commercial with an emphasis on sales. The digital health sales veteran’s new role includes responsibilities for overseeing sales and commercial operations for Eko’s AI and telemedicine software platforms for health systems, practices and providers worldwide, according to a news release. […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
340 organizations ask Congress for telehealth to stay
Today, 340 companies signed a letter sent to Congress to urge leaders to make COVID-19-related telehealth flexibilities permanent. Representing all 50 states, Washington, D.C., and Puerto Rico, the signees are seeking to stop the potential for telehealth flexibilities to disappear, should Congress fail to act before the COVID-19 public health emergency expires, according to a […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
$4.2m project with GE would develop air transport vital-signs patch
The Nano-Bio Materials Consortium (NBMC) announced this week that it has launched a project with GE Research to develop a medical-grade wireless patch that monitors the vital signs of medical patients during emergency air transport. The device would advance medical care coordination, records management and patient outcomes in aeromedical evacuation and help drive advances in consumer-based telehealth, according to […]
FDA OKs Circadia’s radar-powered tool in battle against COVID-19
Healthcare staff monitoring COVID-19 patients for respiratory distress will have a new radar-powered tool at their disposal thanks to an expedited FDA clearance for Circadia Health. London-based Circadia Health announced today the agency gave a green light to its Contactless Respiration Rate (CResp) monitoring systems and c100 device. “Our C100 uses radar to wirelessly look […]
Zimmer Biomet updates remote care system used with Apple Watch
Zimmer Biomet (NYSE:ZBH) this week said it is creating a remote care management system with new MyMobility features on the Apple Watch. The new features expand upon existing work between Apple and Zimmer Biomet, who launched the care management system in October 2018 to transform pre- and post-operative joint replacement experience. MyMobility’s features Measure gait quality, […]
Tandem Diabetes Care acquires Sugarmate mobile app
Tandem Diabetes Care (NSDQ:TNDM) said today that it has purchased Sugarmate — as mobile app that helps people better manage their diabetes. Financial terms of the deal were not disclosed. Nearly 30,000 people relying on insulin pumps or multiple daily injections presently use the Sugarmate app. Get the full story on our sister site Drug Delivery […]
- 1
- 2
- 3
- …
- 63
- Next Page »
