FDA

By Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
By Dave Muoio 04:32 pm March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA. On Friday evening, the agency released an alert to consumers...
By Dave Muoio 04:50 pm March 20, 2020
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency. The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume...
By Dave Muoio 11:56 am March 4, 2020
The FDA is warning of new cybersecurity vulnerabilities affecting Bluetooth Low Energy communications technology used in certain medical devices. According to the agency, the issue could allow unauthorized users to wirelessly crash a device, prevent it from working or access functions limited to its users. The FDA says the vulnerabilities – referred to as "SweynTooth" by the researchers who...
By Dave Muoio 04:38 pm February 7, 2020
The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert. “Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and...
By Dave Muoio 01:44 pm February 5, 2020
Into the Great White North. MDClone, a patient data-focused startup, told MobiHealthNews that it will be debuting its platform in Canada thanks to a new partnership with The Ottawa Hospital. With it, the hospital’s practitioners and researchers will have a synthetic set of patient data that, although statistically comparable to the original, includes no identifiable information so that medical...
By Laura Lovett 01:36 pm February 3, 2020
Sony’s smart operating platform NUCLeUS Operating Room scored FDA 510(k) clearance late last week. The new system allows clinicians to capture, store and share OR videos, scans and other patient data throughout its hospital network. This will also allow videos, including 3D videos, to be captured in "near real time.” The latest tool was designed to reduce hardware requirements in the operating...
By Dave Muoio 01:16 pm January 30, 2020
This week in M&A. Imprivata, a tech company providing identity and authentication tools designed specifically for healthcare, has acquired GroundControl Solutions, inc., which is known for its automated enterprise mobile device management software. Imprivata anticipates that the purchase of this new tech will augment its platform with new capabilities for large and small healthcare...
By Laura Lovett 11:51 am January 28, 2020
This morning digital cardiac health startup Eko announced that its atrial fibrillation and heart murmur detection algorithm landed a 510(k) FDA clearance. The new algorithms are designed to integrate with Eko’s stethoscope, which is already on the market, and be used by healthcare providers.  The company said it plans to add more algorithms in the future. Next up will be an ECG-based algorithm...
By Dave Muoio 01:40 pm January 27, 2020
Abbott’s Infinity Deep Brain Stimulation (DBS) system has received an expanded clearance from the FDA that now permits the targeted stimulation of a new area of the brain associated with Parkinson’s disease symptoms. By now targeting the internal globus pallidus alongside the subthalamic nucleus and ventral intermediate nucleus, the company says that its system “is now the only directional DBS...