Regulation

By Tammy Lovell 05:15 am February 12, 2020
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year. But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime. The new EU MDR came into force on May...
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 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 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...
By Laura Lovett 03:16 pm January 23, 2020
Wearable sensor company VivaLNK got the FDA nod for its Multi Vital ECG Sensor and software development kit (SDK) this morning.  This comes roughly a month after the technology landed a CE Mark, allowing the product to be marketed in the European Union.  The new product, which includes a light weight reusable sensor and corresponding SDK, allows developers and providers to have direct control...
By Dave Muoio 11:13 am January 22, 2020
Editor's note: This story has been updated with information from Verily's announcement of the clearance.  Verily, the life sciences research subsidiary of Alphabet, has received FDA 510(k) clearance for an augmented version of its prescription Study Watch wearable that includes some form of arrhythmia monitoring. The Study Watch With Irregular Pulse Monitor is classified by the FDA as a “...
By Dave Muoio 03:18 pm January 9, 2020
Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and connected home-use spirometer device. According to the FDA’s premarket notification database, the Stockholm, Sweden-based company submitted its application in November 2018, and received the decision last Thursday. The Air Next is designed for patients with...
By Dave Muoio and Laura Lovett 09:13 am December 30, 2019
The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy.  On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more...