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FDA CLEARANCE
Butterfly Network gets FDA clearance for AI ultrasound pregnancy toolUnlike traditional ultrasound machines that rely on expensive piezoelectric crystals, Butterfly's device uses a single silicon chip for w...- Biomoneta earns US-FDA Class II clearance for medical air cleanersBiomoneta Research, a Bengaluru healthtech firm, has secured US FDA clearance for its Avata Rx air cleaner. This allows the company to intr...
- Apple Watch hypertension feature wins FDA nod, rollout next week: ReportThe company unveiled a blood pressure monitor in its latest Apple Watch at the September 9 event, where it also introduced a refreshed iPho...
- Biocon shares zoom 4% as Jefferies upgrades to "hold" amid positive news inflow, sets Rs 400 targetBiocon share price: This upgrade reflects a more positive outlook on the company following recent favorable news flow, particularly concern...
- DeepTek.ai secures US FDA clearance for its ground-breaking chest X-ray AI SolutionPartnered with TATA Capital and NTT DATA Japan, the leading medical imaging AI startup, DeepTek.ai, has announced that it has received clea...
- Elon Musk's Neuralink to start human trial of brain implant for paralysis patientsBillionaire entrepreneur Elon Musk's brain-chip startup Neuralink said on Tuesday that it has received approval from an independent review ...
- Musk expects brain chip startup Neuralink to implant 'first case' this yearLast month, Neuralink said it received US Food and Drug Administration (FDA) clearance for its first-in-human clinical trial, a critical mi...
- Indian pharma compliance standards improving, regulatory risks here to stay: Ind-RaAs Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...
- Maharashtra to set up single-window clearance system for pharma companiesEarlier, around 3,000 pharma companies had their manufacturing units in Maharashtra.
- Despite spending big on legal & professional consultants, FDA woes continue to haunt pharma companiesSun Pharma’s Halol plant received four observations three months after it received the clearance from the USFDA that had ended a two-year i...
- 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta G G, Estima PharmaSun Pharma's Mohali plant import alert has been lifted after approximately three and a half years whereas Halol plant has recently been aud...
- USFDA’s notice may shave off 2-6% from Sun Pharma's EPS in FY18Analyst believes that Form 483 observations may delay the clearance of Halol facility and see full remediation only by first quarter of cal...
- Sun Pharma Halol site being inspected by US FDA: SourcesOver its recent call with investors, Sun Pharma management had maintained that the remediation exercise at the site have been completed and...
- Switch to the smartest thermometer: 'Thermo' can take your temperature without even touching skinThe Thermo appears to be a tiny mirror & behind it is an array of 16 infrared thermometers that can take fast temperature readings.
- How faster USFDA nods will help Indian generic drug makersA long spell of sluggish approvals for generic drugs in the US may be nearing an end with early signs of a rebound.
- USFDA lifts sales ban as Indian drug companies take corrective actionsCompanies which have taken corrective action after being penalised for violating FDA norms have been allowed to resume sales.
- E-cigarettes violate drug rules: FDAElectronic cigarettes sold in the US are being marketed illegally as smoking-cessation aids, the Food and Drug Administration said.
- Opto Circuits gets USFDA nod for new patient monitoring deviceThe approval has been granted to the firm's US subsidiary, Criticare Systems Inc, by the US Food and Drug Administration.
- Lupin plants get USFDA nod; co to sell new productsDrug maker Lupin has received clearance from the US drug regulator for its plant at Mandideep in Madhya Pradesh, allowing the Mumbai-based ...
- US FDA inspects Lupin's new plant in IndoreThe US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...
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