Lunit Inc. has won FDA approvals for the company’s breast cancer detection product Lunit Insight MMG and the triage and notification software Lunit Insight CXR Triage, only days apart. Lunit Insight MMG is an artificial intelligence (AI) product for breast cancer detection from mammography images. Lunit’s second approval is for Lunit Insight CXR Triage, its AI-powered chest X-ray triaging product.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pear, Strados Labs, Theradaptive.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axiology Labs, Biocept, Brain Scientific, Illumigyn, Imidex, Laurel Bridge, Lemon Medical, LOK, MGC, Nobel Biocare, Pathogendx, Peramare, Sprintray, Vela Diagnostics.
LONDON – Medical research charities that form an integral part of the U.K. health research system are still reeling from the impact of COVID-19 and now expect it will be three years before funding returns to pre-pandemic levels.
Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.
Shanghai Aohua Photoelectricity Endoscope Co. Ltd. was listed on the Shanghai Stock Exchange Star Market in China on Nov. 15, with the share prices jumping 71.16% on the first day. Aohua Endoscopy offered 33.34 million shares at ¥22.5 (US$3.53) per share. It raised ¥750 million in this IPO, higher than projected ¥640 million it projected to raise.
As the COVID-19 pandemic emerged in early 2020 and med-tech companies stepped up with numerous diagnostic and telehealth solutions, the availability of funding sources began to soar. The med-tech industry has raised a total of $46.9 billion so far in 2021 through 636 financings.
Glyconics Ltd. landed £1.5 million (US$2 million) in an Enterprise Investment Scheme funding round to finance a clinical trial of its diabetes screening tool, Glyconics-SX. The Cambridge, U.K.-based diagnostics company is developing a point-of-care, hand-held device using miniaturized infrared (IR) spectrometry. The technology scans fingernails, assessing glycation to identify diabetes within minutes.
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