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BioWorld - Thursday, May 21, 2026
Home » Topics » Medical technology

Medical technology
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U.K. flag on stethoscope

MHRA goes big with harmonization with IMDRF, ICH

June 16, 2022
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles.
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Galen Gastric concept image

Ibex adds gastric cancer to Galen Gastric AI system approvals

June 16, 2022
By Nuala Moran
Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.
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2022 FDLI Annual Conference

DOJ’s consumer protection branch expanding, and digital health a source of growing scrutiny

June 16, 2022
By Mark McCarty
The U.S. Department of Justice (DOJ) has kept a close eye on medical technology for a number of years, but the department’s consumer protection branch has often lagged behind other DOJ offices where enforcement is concerned.
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Sidekick_BC

Sidekick teams up with Lilly to support breast cancer patients

June 16, 2022
By Annette Boyle
In May, Sidekick Health AB revealed an expanded partnership with New York-based Pfizer Inc. for autoimmune-related conditions. Now, it has joined forces with Eli Lilly and Co. to help patients battling breast cancer with its gamified platform. The companies plan to introduce the integrated digital therapeutic starting in July with the roll out beginning in Germany.
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10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

Boston Scientific grabs majority stake in M.I. Tech for $230M

June 16, 2022
By Catherine Longworth
Boston Scientific Corp. signed an agreement to purchase a majority stake (64%) of M.I. Tech Co. Ltd. for $230 million. The publicly traded Pyeongtaek South Korea-based company manufactures device solutions used in endoscopic and urologic procedures. Boston Scientific has distributed M.I. Tech’s Hanarostent non-vascular stent in Japan since 2015. The deal marks Boston Scientific’s first acquisition of the year, following a busy spending spree in 2021.
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US health agencies told go back to their offices

June 16, 2022
By Mari Serebrov
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
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Regulatory actions for June 16, 2022

June 16, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascensia Diabetes Care, Imagia Canexia Health, Novarad, Senseonics, Sysmex America.
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Other news to note for June 16, 2022

June 16, 2022
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bonesupport, Dariohealth, Dia Imaging, Diadem, GBS, Hollister, Intelerad, Intelligent Fingerprinting, Kurin, Life Science Biosensor Diagnostics, Magnolia Medical, Pieriandx, Solera Health, Stimwave, Syapse.
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In the clinic for June 16, 2022

June 16, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Centricity, Venturemed.
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Financings for June 16, 2022

June 16, 2022
Med-tech firms raising money in public or private financings, including: Aerin Medical, Aidoc, Artio Medical, Brain Scientific.
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