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Regulation

Mar
24

Huma receives multi─condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

Huma receives multi─condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform unknown Huma Therapeutics
2 min read
Mar
17

Digital Health Laws and Regulations Report 2023

Digital Health Laws and Regulations Report 2023 The Global ... unknown 1. Introduction The landscape of digital health has changed dramatically
27 min read
Mar
16

TytoCare receives FDA 510(k) for wheeze detection software

TytoCare receives FDA 510(k) for wheeze detection software unknown Virtual primary care company TytoCare received FDA 510(k) clearance
1 min read
Mar
13

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor unknown Respiree, a med tech spinoff of Singapore'
1 min read
Mar
11

FDA updates for Week of March 6, 2023

FDA updates for Week of March 6, 2023 unknown FDA approves novel nasal spray for migraine. The FDA has approved
5 min read
Mar
11

Europäischer Rat beschließt MDR-Änderungen

Europäischer Rat beschließt MDR-Änderungen Folker Lück Der Europäische Rat hat grünes Licht für Änderungen an der Europäischen Medizinprodukteverordnung (MDR) gegeben.
1 min read
Mar
07

FTC takes 'shot across the bow' on health data, attorneys say

FTC takes 'shot across the bow' on health data, attorneys say unknown Regulators are cracking down on the
2 min read
Mar
05

Theranica receives FDA 510(k) for migraine prevention device

Theranica receives FDA 510(k) for migraine prevention device unknown Prescription digital therapeutic developer Theranica announced it had received FDA
1 min read
Mar
05

French watchdog unveils conditions of use for new digital health insurance ID

French watchdog unveils conditions of use for new digital health insurance ID Alessandro Mascellino France’s CNIL (Commission nationale de
1 min read