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Regulatory front for Dec. 27, 2019

Dec. 27, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Medical IP wins green light from FDA for its medical 3D printing software Medip

Dec. 27, 2019
By Jihyun Kim
HONG KONG – South Korea’s Medical IP Co. Ltd., an artificial intelligence (AI)-based medical 3D printing and software company, has won the FDA’s nod for its medical imaging analysis solution Medical Image Processing (Medip).
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FDA Approved stamp

FDA grants accelerated approval for Padcev to treat urothelial cancer

Dec. 24, 2019
By Lee Landenberger
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
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FDA sign

Advamed argues device-specific guidances suffer from overly narrow scope

Dec. 24, 2019
By Mark McCarty
The U.S. FDA’s attempt to use objective performance criteria for class II devices offers several advantages for device makers. However, the Advanced Medical Technology Association (Advamed) said in comments to the docket for two such sub-guidances that the documents are too narrowly scoped to be of much use in many instances.
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pentax-medical-discover-12-24.png

Pentax Medical gets CE mark for AI-based polyp detector Discovery

Dec. 24, 2019
By Jihyun Kim
HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.
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FDA Approved stamp with pills, bottle, blister pack
A sleigh full of approvals

FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine

Dec. 24, 2019
By Michael Fitzhugh
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.
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Ubrogepant approved by the FDA for migraine

Dec. 24, 2019

Lumateperone approved in the U.S. for schizophrenia

Dec. 24, 2019
Augmedics-xvision-headset-12-23.png

FDA greenlights Augmedics’ AR system for spinal surgery

Dec. 23, 2019
By Meg Bryant
Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery.
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FDA Approved stamp with pills, bottle, blister pack
A sleigh full of approvals

FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine

Dec. 23, 2019
By Michael Fitzhugh
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.
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