The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.

After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.

The narrative that a little company has little chance of beating a big company in patent lawsuits doesn’t always play out in the real world, and such was the case in a dispute between Snyders Heart Valve LLC and St. Jude Medical. The U.S. Court of Appeals recently handed Snyders a win in the court’s reversal of an inter partes review (IPR) of a Snyders patent for heart valves, the second time in the past year Snyders prevailed over the larger company in a patent hearing at the Federal Circuit.

With more than two months of financings yet to record for the year, the med-tech industry has already raised more money through IPOs and venture capital rounds than in each of the prior four years. But fewer funds collected through follow-on offerings and private placements puts 2021 about 30% below the full-year total for 2020, which was $59.7 billion.

On the last day of this year’s Molecular Targets meeting, an annual joint conference of the American Association for Cancer Research, the National Cancer Institute and the European Organization for the Research and Treatment of Cancer, the final plenary went from molecular to macro in a lively discussion of the biggest roadblock in cancer drug development, and what can be done to improve it.

Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.