Month: January 2016

The U.S. Food and Drug Administration issued in January 2016 a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.  The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.  The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats.

The Diabetes Research Institute (DRI) has had positive results in the first patient in a Phase I/II, pilot trial of a technique it expects could result in a bioengineered mini organ.  This could mean a breakthrough in the race to develop an artificial pancreas that produces insulin in Type 1 diabetic patients.

As med tech companies roll out innovative radiation devices to treat breast cancer, medical experts are debating the pros and cons of a new technique that could be less expensive and more convenient than traditional therapy for the disease.

Google has faced some stumbling blocks with Google Glass since launching the product in 2013, deciding earlier this year to stop selling the device to consumers in light of waning sales.  However, the company is set to meet increased demand for the product among device makers as a new version of Glass hits the market.

The regulatory territory around e-cigarettes is murky. It’s clouded by scientific issues around the potential and relative harm they cause, as well as governmental concerns around its oversight as a tobacco or a smoking cessation product.

In a bid for regulatory convergence with other international regulators, the FDA announced it is looking for companies to participate in a pilot program involving the use of a common international format for regulatory submissions like 510(k)s and PMAs.

New medical devices for rectal cancer surgeries are helping patients forgo colostomies, shifting more individuals toward a new procedure that requires fewer external adjustments, according to medical experts.

A team of researchers has developed a “blood clot probe” for finding the precursor of stroke and heart attack using positron emission tomography. The method worked–at least on rats.

Owlet Baby Care has expanded its Series A round by $6 million.  It also picked up another $1 million in a National Institutes of Health (NIH) grant–to bring its fundraising total to $9.2 million.  The startup will use that cash for a fall launch of its Owlet Baby Monitor that is intended to alert parents via smartphone if their baby stops breathing.

A study by two psychologists at Germany’s Max Planck Institute on Human Development poured cold water on the use of brain electrical stimulation techniques, lending support to those who dismiss the methods of supposedly improving memory and mood as pseudoscience.