Regulation

Pregnant woman laying on a couch monitoring her pregnancy with INVU by Nuvo while the father watches
By  Mallory Hackett 11:43 am June 10, 2021
Remote pregnancy monitoring company Nuvo Group announced today the FDA has granted supplemental 510(k) clearance to add a new uterine activity module to its INVU system. INVU is a physician-prescribed, wearable pregnancy monitoring system that allows women to remotely collect fetal and maternal heart rates – and now uterine activity – while sharing data in real-time with their doctor. The FDA...
EyeYon Medical, CE Mark, EndoArt, corneal edema
By  Sophie Porter 08:29 am June 8, 2021
Israeli ophthalmology startup, EyeYon Medical, has received a CE Mark for its flagship product EndoArt, the world’s first synthetic corneal implant designed to counteract corneal edema. Edema is the excess build-up of fluids in the cornea caused by damaged endothelial cells, which usually regulate hydration levels in the eye. It can result in irreversible scarring, pain and even blindness....
Caregiver records child on smartphone using Cognoa's Canvas Dx diagnostic software
By  Mallory Hackett 12:42 pm June 3, 2021
Pediatric behavioral health company Cognoa has received FDA De Novo classification for its autism spectrum disorder (ASD) software diagnostic aid, Canvas Dx. The ASD diagnostic tool is designed to help primary care clinicians and pediatricians evaluate and diagnose suspected cases of autism among children. It uses machine learning algorithms to analyze videos of the child’s behavior and responses...
Medical devices, European Commission, MDR, Medical Devices Regulation, COCIR
By  Tammy Lovell 11:50 am May 26, 2021
The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress. The regulation entered into force in May 2017, replacing the Medical Devices...
Remote monitoring
Remote monitoring (RM) could revolutionize the way care is provided for people with chronic disease, particularly for people of color and low-income people, who experience worse outcomes than the general population as a result of systemic racism and discriminatory policies. Unfortunately, scarce provider reimbursement for RM services and devices presents a barrier to adoption and risks...
Peloton
By  Laura Lovett 02:17 pm May 20, 2021
Just weeks after Peloton pulled its treadmills from the market, it rolled out a new safety feature on its Tread+ that locks the device after 45 seconds of inactivity outside a class or after a user puts it to sleep. Peloton's treadmills are associated with more than 70 reported injuries and one child death. In early May, the company voluntarily recalled its treadmills after facing pressure from...
Hand holding Bigfoot rapid-acting smart insulin pen
By  Mallory Hackett 11:58 am May 10, 2021
This morning, Bigfoot Biomedical announced it has received FDA 510(k) clearance for its Bigfoot Unity Diabetes Management System. The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy. Included in the Bigfoot Unity System are two smartpen caps for both rapid- and long-acting insulin, a connected mobile app, an...
Viome's Health Intelligence kit
By  Mallory Hackett 11:24 am May 7, 2021
Viome, maker of at-home test kits for gut, immune and cellular health, has received FDA breakthrough device designation for its mRNA analysis technology and artificial intelligence platform that detect early signs of oral cancer and throat cancer. The FDA designation validates the technology used in Viome’s at-home Health Intelligence Test that analyzes users’ microbial, human and mitochondrial...
KardiaMobile 6L being used.
By  Mallory Hackett 11:42 am April 22, 2021
Personal electrocardiogram maker AliveCor is seeking to ban U.S. sales of Apple Watches after claims that the tech giant infringed on its patented technology. The company announced this week it has filed a complaint with the U.S. International Trade Commission alleging that Apple breached patent laws on three of AliveCor’s patented devices. AliveCor asserts that Apple knowingly copied its...
Peloton Tread+
By  Laura Lovett 11:40 am April 19, 2021
During the COVID-19 pandemic, Peloton's connected bike and treadmill became the "it" workout devices. Last quarter, the workout giant beat its revenue expectation by more than $34 million. But the company is now on rocky footing. On Saturday, the U.S. Consumer Product Safety Commission issued a warning about the dangers of the Peloton Tread+ after a slew of injuries in small children, including ...