FDA grants marketing authorization for Invitae DNA
The FDA cautioned that the prescription test is “not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer,” and that the test can report false positive and false negative test results. Image Credit: StockSmartStart / Shutterstock. The US Food and Drug Administration (FDA) has granted de novo marketing […]
SeaStar’s selective cytopheretic device wins FDA breakthrough designation
Overactivity of the immune system can lead to organ damage and can even lead to multi-organ failure. This is known as a cytokine storm. Image credit: Shutterstock/Kateryna Kon. The US Food and Drug Administration (FDA) has granted breakthrough device designation to SeaStar’s selective cytopheretic device (SCD), meaning the agency will fast-track the product’s route to […]
Israeli hospital trials AI tools to identify coronary blockages
The hospital trialed the new AI tools on 326 eligible patients, finding that 58% of them had moderate or severe calcium build-up. Credit: Shutterstock / Gorodenkoff An Israeli hospital has used AI to identify calcium in the coronary arteries of CT scan patients, with the use of a deep learning algorithm. The Tel Aviv-based hospital […]
UK equity firm set to buy up shares of Synlab for $1.3bn
Credit: Shutterstock / Ground Picture Private equity firm, Cinven, has made a move to buy out the remaining shares of the Germany-based diagnostics company, Synlab, valuing the company at €2.24 billion ($2.37 billion). The UK-based equity firm has long since owned 43% of the firm but seeks now to acquire the remainder of its shares, […]
Wiping away the shame of male infertility with medtech
According to GlobalData’ market model, the consumable ART devices market is forecast to grow at a compound annual growth rate (CAGR) of 6%, with the global market value surpassing $440 million by 2030. Credit: Nadezhda Moryak/Pexels Starting a family is the decision of both prospective parents but infertility, a disease of the reproductive system, impacts […]
Wiping away the shame of male infertility with medical
According to GlobalData’ market model, the consumable ART devices market is forecast to grow at a compound annual growth rate (CAGR) of 6%, with the global market value surpassing $440 million by 2030. Credit: Nadezhda Moryak/Pexels Starting a family is the decision of both prospective parents but infertility, a disease of the reproductive system, impacts […]
Leo Cancer Care and THERYQ collab to deliver FLASH radiotherapy
FLASH therapy is a form radiation therapy that shows potential targeting cancer cells efficiently while reducing side effects from the treatment. Credit: Gorodenkoff/ Shutterstock FLASH radiotherapy medical device specialist, THERYQ and provider of upright radiotherapy solutions, Leo Cancer Care have teamed up to deliver FLASH radiotherapy into mainstream clinical practices. The partnership promises to deliver faster, […]
Signal: Philips knew about ventilator defects for years before recall
The potentially deadly respirators were used by children, veterans and the elderly. Photo: Shutterstock. Multinational electronics and medical device manufacturer Philips knew for over a decade about the defects in its respiratory devices before issuing a recall in 2021, it has been reported. According to a ProPublica and Pittsburgh Press-Gazette joint investigation, the company’s respirator […]
AI is a pillar of the healthcare system of tomorrow, but limitations remain
AI’s implementation in healthcare might take longer than other industries, but its widespread application in the future is inevitable. Image credit: Shutterstock/elenabsl. Experts in the biotech and medtech industries descended upon Europe’s geographical centre last week to discuss all things life sciences. A common theme, as Medical Device Network found out, was that automation – […]
Affluent Medical eyes US market for mitral valve device
Abbott is occupying 99% of the market share in the transcatheter mitral valve repair (TMVR) industry. Image Credit: Pepermpron/ Shutterstock. Affluent Medical plans to engage with the US Food and Drug Administration (FDA) regarding the clearance of its mitral valve repair device, Kalios. The French company will base its application on the positive one-year data […]