Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med tech company which will focus on revolutionizing cardiac valve replacement and stroke treatment through AI-driven autonomous mini-robots and innovative implants.

Smith+Nephew plc (S+N) has agreed to acquire Integrity Orthopaedics Inc. for up to $450 million in a bid to strengthen its shoulder repair portfolio. The move comes as the company looks to accelerate its growth with strategic investments, with the deal expected to be an important step in its ambition in becoming a global leader in sports medicine.

Cellbxhealth plc, previously called Angle plc, appointed CEO Peter Collins along with several non-executives to its board as it embarks on a new strategic direction. Over the past few months the company overhauled its management team, reduced its workforce by 60% and raised £8.2 million (US$11 million) as it changes focus from research to commercialization of its Parsortix system, a platform that captures and harvests circulating tumor cells (CTCs).

The U.K. Medicines and Health Care Products Regulatory Agency provided an update of its guidance for clinical investigations for medical devices and is offering a temporary waiver of the fees for registration of clinical studies to small manufacturers.

Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available.

It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.

Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.

The U.K. National Institute for Health and Care Excellence has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.

Stereotaxis Inc. secured U.S. FDA approval for its Magic magnetic interventional ablation catheter, marking a key step in the company’s effort to evolve from a niche robotics supplier into a more vertically integrated electrophysiology technology provider. The approval positions Magic as Stereotaxis’ first proprietary robotic ablation catheter in the U.S. and follows a series of regulatory and commercial milestones in recent months that reset the company’s growth narrative.

Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of earbuds the company hopes will transform how the brain activity is monitored, helping diagnose and track a number of conditions affecting the brain.