FDA

By Dave Muoio May 21, 2019
Minneapolis-based NightWare — maker of a smartwatch therapeutic for people with nightmare disorder and PTSD-driven nightmares — has received breakthrough therapy designation for its in-development product. In addition, the company is launching two new placebo-controlled randomized clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs...
By Dave Muoio May 20, 2019
On Friday, the FDA issued a warning to patients and providers describing the dangers of diabetes management devices and software that haven’t been assessed by the agency. These include any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system. “These...
By Dave Muoio May 15, 2019
Aidoc, an Israeli provider of artificial intelligence products for radiologists, announced today that it has received FDA clearance for a tool that identifies potential cases of pulmonary embolism — a blockage in one of the lung’s pulmonary arteries — for expert review. “We chose to focus on this product because these are patients who might not necessarily have clear symptoms of pulmonary...
By Tammy Lovell May 14, 2019
Governments, industry and regulators worldwide are trying to make the pharmaceutical supply chain more bullet-proof and the use of blockchain based track and trace technology has been hailed as a possible solution. Blockchain is an electronic cryptographic ledger which creates an immutable record of all events throughout the supply chain, allowing digital information to be distributed without...
By Dave Muoio May 13, 2019
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced yesterday that it has received an 510(k) clearance for an artificial intelligence tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall. The HealthPNX product scans a chest X-ray or digital radiography scan for signs of the condition,...
By Dave Muoio May 13, 2019
Mobile consumer ECG maker AliveCor announced today that its long-teased six-lead ECG device has been cleared by the FDA and will be available to customers in June of this year. “[The KardiaMobile 6L clearance] is a big deal for us, and it’s important for patients and physicians because they will be able to get a materially improved view into patients’ hearts,” Dr. Jacqueline Shreibati, chief...
By Dave Muoio May 7, 2019
The FDA has cleared eMurmur ID, a software screening device that uses a smartphone, third-party digital stethoscope and machine learning to automate the detection of heart murmurs. According to Ottawa, Canada-based eMurmur, the cloud tool identifies and classifies both dangerous and healthy heart murmurs, as well as the absence of a murmur and S1 or S2 heart sounds. The platform includes a mobile...
By Dave Muoio May 2, 2019
The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias. According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias,...
By Dave Muoio April 25, 2019
The last couple of months saw a pair of regulatory clearances from mobile ECG maker AliveCor surface on the FDA’s 510(k) premarket notification database — the first in March for something called KardiaAI, and the latter a dual-update for the company’s existing KardiaMobile and KardiaStation platforms for consumer and point-of-care use. With AliveCor keeping mum at the time, Babyforyou.net.ua...
By Dave Muoio April 24, 2019
In February, Edinburgh, Scotland-based Current Health (formerly snap40) received FDA clearance for clinical use of its artificial intelligence-enabled device and platform for remote patient monitoring in the hospital. Taking things one step further, the company announced this morning that it has also received the regulator’s blessing for use in post-acute care — what Current Health is calling “...
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