Aatru Medical LLC has received FDA 510(k) class II clearance for a platform that turns its back on electro-mechanical components in other negative pressure wound therapy (NPWT) systems. Deployed for closed surgical incision applications, the Negative Pressure Surgical Incision Management System (NPSIMS) is a single-use, disposable platform that could help reduce the 20% of hospital infections attributed to surgical site infections (SSI).

After weeks of heated rumors, Baxter International Inc. and Hillrom Holdings Inc. reported they have reached terms on a blockbuster deal. Baxter will acquire Hillrom for $156 per share in cash, giving the transaction an equity value of $10.5 billion and a total enterprise value of $12.4 billion, after factoring in the assumption of debt. The deal is expected to close in early 2022. The acquisition continues the fast and furious pace of med-tech acquisitions in 2021, a sharp change from the lethargic deal flow seen in 2020. So far, the sector has seen 407 transactions this year, more than four times the 97 posted in the pharma segment.

Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.

Ventura Capital has led a $60 million series A investment round into consumer genetic testing company Dnanudge Ltd. It is the first major fundraising round for the London-based company, which will be used to accelerate deployment of its DNA testing service worldwide. Dnanudge is aiming to tap into the lucrative consumer DNA testing market with Dnaband, a wearable device that stores digital DNA and helps users make healthier choices by personalizing shopping behaviors. The company is also planning a service for personalized skincare shopping.

Onkos Surgical Inc. nabbed an additional $15 million from its existing investors in a series C fundraising round. The Parsippany, N.J.-based company plans to use the new cash to accelerate research and development for its product line which is designed to meet the specialized needs of oncology patients who require orthopedic surgery and the surgeons who work with them.

The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.