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BioWorld - Monday, December 29, 2025
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
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Regulatory actions for Jan. 21, 2021

Jan. 21, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical Systems, Covaxx, Lumiradx, Retia Medical, Zimmer Biomet.
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Illustration showing how opto-acoustic technology detects breast cancer

Seno secures nod for noninvasive breast cancer diagnostic imaging technology

Jan. 20, 2021
By Annette Boyle
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.
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French flags on building
Financial constraint

France is keeping up price pressure on medical device reimbursement

Jan. 20, 2021
By Bernard Banga
PARIS – France’s Comité Economique des Produits de Santé (CEPS), which reports to the Ministry of Health, has released its latest financial figures for medical device reimbursement. Health insurance expenditures amounted to $11.6 billion during the last full financial year reported by CEPS, representing annual growth of 4.66%. Over the last two years, more than half of expenditures have focused on four therapy areas: orthopedics, pulmonology/ENT, cardiac and vascular systems, and diabetes.
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Regulatory front for Jan. 20, 2021

Jan. 20, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS, OIG differ on CERT program.
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Regulatory actions for Jan. 20, 2021

Jan. 20, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio.
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China U.S. deal

Many unkept promises, but USTR sees progress in China’s trade commitments

Jan. 20, 2021
By Mari Serebrov
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept.
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US flag, Department of Health and Human Services flags

HHS farms out LDT review to private company as Hahn calls for FDA independence

Jan. 19, 2021
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has awarded a contract for validation of lab-developed tests (LDTs) for the pandemic to a private company, a move that was apparently an effort to address the resource crunch at the U.S.
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Product image

Depuy Synthes gets FDA nod for Velys for use with the Attune total knee system

Jan. 19, 2021
By Liz Hollis
Johnson & Johnson has been looking to make a big splash in robotics. Now, its Depuy Synthes unit has made progress on this front, gaining U.S. FDA clearance for the Velys robotic-assisted solution designed for use with the Attune total knee system. The solution aims to help simplify surgeons’ existing workflow around total knee replacement.
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Regulatory front for Jan. 19, 2021

Jan. 19, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA to hold webinar for respirator policy.
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Regulatory actions for Jan. 19, 2021

Jan. 19, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardiovascular Systems, Cytosorbents, Depuy Synthes, Impulse Dynamics, Medibio, Occlutech, Q Core Medical, Seno Medical, Theralight, Transenterix.
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