Investors are backing neurostimulation device company Stimdia Medical Inc. with $16 million, in the first tranche of a series B offering expected to total $30 million. The Minneapolis-based company is developing a device that stimulates the phrenic nerves in a patient’s neck to exercise the diaphragm during mechanical ventilation and minimize ventilation-induced diaphragmatic dysfunction (VIDD).
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
The U.S. FDA has granted a breakthrough device designation to Ancora Heart Inc. for its Accucinch ventricular restoration system. The minimally invasive treatment is intended to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates. Russian Minister of Health Mikhail Murashko told the group his agency’s top priority is an uninterrupted drug supply. He recognized that dialogue between the government and manufacturers is necessary to maintain that supply.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Incepto Medical, Johnson & Johnson Vision, Pulnovo Medical, Subtle Medical, Suneva Medical, Viveon Health.
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