The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said. Read More
The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking. Read More
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit. Read More
Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer. Read More
Axogen Corp. has developed a suite of products to meet the needs of the 1 million patients in the U.S. who undergo surgery each year to repair peripheral nerve damage. While the process the company uses to decellularize nerves harvested from human donors and clear them of all cellular debris so they can be used as scaffolding for nerve regeneration has been successful, with the Recon study, Axogen aims to increase the utility of the purified nerve tissue by adding materials that promote growth. Read More
Steven Roy, CEO of Convergence Medical Sciences Inc., has designed a low-cost device that boosts the number of patients on a single ventilator to four simultaneously. To do this, he is collaborating with Calgary-based consulting engineers, Exergy Solutions Inc., to take the international Red Dot design winner through the Health Canada approval process. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cognetivity Neurosciences, Geneoscopy, Inotec AMD, Perspectum. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Bardy Diagnostics, Dariohealth, Hillrom, Histosonics, Tada Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360. Read More
