The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy devices, but a new problem has emerged that promises to add yet more drag to the process. Amie Smirthwaite, senior vice president for innovation at RQM+, said EU member states’ competent authorities seem bent on pressing notified bodies (NBs) to treat guidance by the Medical Device Coordination Group (MDCG) as regulation, with the net result that “you almost need guidance for the guidance” in order to successfully navigate the EU market.
Rhythm Diagnostic Systems SA (RDS) received €1 million (US$1.1 million) from Capital Grand Est, the first venture capital (VC) firm to join its investor pool, taking its total seed capital raised to €13 million. RDS will use the funds to progress toward the next stages in the development of its Multisense product, a remote patient monitoring solution, including market launch, once it receives CE mark from the European authorities expected by the end of the year.
The U.K. has launched the first-of-its-kind national total-body positron emission tomography (PET) imaging platform that will be ‘game-changing’ for clinical research. Funded with £32 million (US$39 million) from the government, the National PET Imaging Platform (NPIP) will enable clinicians and researchers to access never-before-seen data that will improve the detection, diagnosis and treatment of complex, multi-organ diseases.
Boston Scientific Corp.’s plan to acquire Relievant Medsystems Inc. is part of its ongoing effort to address chronic pain which is significantly impacting the quality of life of millions of people. Relievant’s Intracept intraosseous nerve ablation system will give Boston Scientific another tool in its armory to tackle chronic pain which already includes radiofrequency ablation (RFA) solutions and spinal cord stimulator (SCS) systems.
Cordis Corp. covered its bets a bit as it closed the acquisition of M.A. Med Alliance SA (Medalliance) announced almost a year ago. While the total payment for the company could total $1.135 billion, it could take six years for the owners of privately held Medalliance to see most of the funds.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
Inventors from the International School of Advanced Studies (SISSA) in Trieste, Italy reported filing a patent for a graphene-based device for the targeted mucosal and transmucosal delivery and/or controlled release of active pharmaceutical ingredients (APIs) for various therapeutic applications when on-demand drug administration is needed.
The U.S. Securities and Exchange Commission (SEC) has issued the final order concluding an action against Baxter International Inc. over the company’s use of accounting mechanisms to produce gains by manipulating foreign exchange transactions. While these activities are said to have been undertaken entirely at the behest of only two employees, the agreement will cost Baxter $18 million and serves as a cautionary tale about a lack of supervision of employees charged with managing company funds.
Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
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