FDA

By Dave Muoio June 17, 2019
The past week has seen two FDA clearances awarded to Israeli companies building artificial intelligence analysis tools for medical imaging. The first, announced last Tuesday, was Aidoc’s tool for triaging cervical spine fractures. Much like the company’s prior offerings, the new product analyzes images to prioritize high-risk cases for review by a radiologist, and does so within the specialist’s...
By Jonah Comstock June 10, 2019
Caesarea, Israel-based Itamar Medical received FDA 510(k) clearance last week for a new disposable home sleep apnea test (HSAT) called WatchPAT One. The device is smartphone-connected; patients pair the wearable to their phone before sleeping with the device, which straps around the wrist but also includes a sensor that goes over the tip of the finger and another that affixes to the chest, both...
By Dave Muoio June 10, 2019
The FDA has granted De Novo clearance to a prescription nerve stimulation device for the reduction of functional abdominal pain. The device is intended for use by adolescents and teens with irritable bowel syndrome in combination with other therapies. Developed by Innovative Health Solutions, the IB-Stim devices is a single-use electrical nerve stimulator. When placed behind the patient’s ear, it...
By Jonah Comstock June 7, 2019
Implantable CGM company Senseonics has received approval from the FDA for the non-adjunctive indication for its Eversense device. Senseonics is only the third company to secure this indication, which allows a CGM to be used for insulin dosing in lieu of a fingerstick glucometer, though patients will still need to use fingersticks twice a day for calibration. The company plans to go live with the...
By Dave Muoio June 4, 2019
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program. What to expect from Pre-Cert The question has only become more pertinent since the agency released its 1.0 Working Model in January and, just a couple weeks ago, began seeking new De Novo...
By Dave Muoio May 22, 2019
The FDA has put out a call for new companies to test drive the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update. Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for a software as a medical device (SaMD) during 2019 or early 2020 are...
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...