A Different Case of Penumbra-Reply: A Japanese Framework for Safe and Expedited Access to High-Risk Medical Devices

Kushal T Kadakia¹, Joseph S Ross^{2

3

4}, Harlan M Krumholz^{3

4

5}

Affiliations

¹ Harvard Medical School, Boston, Massachusetts.
² Section of General Internal Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
³ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁴ Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut.
⁵ Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

Comment

Kushal T Kadakia et al. JAMA Intern Med. 2022.

. 2022 May 1;182(5):570-571.

doi: 10.1001/jamainternmed.2022.0105.

Kushal T Kadakia¹, Joseph S Ross^{2

3

4}, Harlan M Krumholz^{3

4

5}

¹ Harvard Medical School, Boston, Massachusetts.
² Section of General Internal Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
³ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁴ Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut.
⁵ Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

No abstract available

Comment on

Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Kadakia KT, et al. JAMA Intern Med. 2022 Jan 1;182(1):59-65. doi: 10.1001/jamainternmed.2021.6626. JAMA Intern Med. 2022. PMID: 34842892
A Different Case of Penumbra: A Japanese Framework for Safe and Expedited Access to High-risk Medical Devices.
Yamamoto H, Kusakabe T, Takahashi M. Yamamoto H, et al. JAMA Intern Med. 2022 May 1;182(5):569-570. doi: 10.1001/jamainternmed.2022.0102. JAMA Intern Med. 2022. PMID: 35285855 No abstract available.